AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA)
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|ClinicalTrials.gov Identifier: NCT03192215|
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : March 19, 2019
- Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.
- Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Apixaban Drug: Aspirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Active treatment will be either apixaban 5 mg or aspirin 81 mg. An adjusted dose of apixaban 2.5 mg will be used for subjects with at least two of the following: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or known serum creatinine greater than or equal to 1.5 mg/dL. There will be six possible study tablets: apixaban 5 mg (regular dose), apixaban 2.5 mg (adjusted dose), apixaban 5 mg placebo, apixaban 2.5 mg placebo, aspirin 81 mg, and aspirin placebo.
All subjects will be randomized to receive active treatment with either active apixaban or active aspirin. Study treatments will be supplied in a double-dummy fashion as apixaban 5 mg (2.5 mg for the adjusted dose) or matching placebo, and aspirin 81 mg or matching placebo.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Eligible patients will be allocated in a 1:1 ratio to apixaban or aspirin using the minimal sufficient balance randomization method to prevent serious treatment imbalances by study site.|
|Official Title:||AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke|
|Actual Study Start Date :||January 19, 2018|
|Estimated Primary Completion Date :||January 18, 2022|
|Estimated Study Completion Date :||April 30, 2022|
Experimental: Active agent: Apixaban
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
Other Name: Eliquis
Active Comparator: Active control: Aspirin
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin 81 mg by mouth once daily.
Other Name: Aspirin Tablet
- Incidence of recurrent stroke [ Time Frame: 4 years ]Recurrent stroke of any type (ischemic, hemorrhagic, or of unclear type)
- Incidence of recurrent ischemic stroke or systemic embolism [ Time Frame: Up to 4 years ]Secondary efficacy outcome A
- Incidence of recurrent stroke of any type plus death from any cause [ Time Frame: Up to 4 years ]Secondary efficacy outcome B
- Incidence of symptomatic intracranial hemorrhage (including symptomatic hemorrhagic transformation of an ischemic stroke). [ Time Frame: Up to 4 years ]Primary safety outcome A
- Incidence of major hemorrhage other than intracranial hemorrhage [ Time Frame: Up to 4 years ]Primary safety outcome B
- Incidence of death from any cause [ Time Frame: Up to 4 years ]Secondary safety outcome
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192215
|Contact: Mitchell SV Elkind, MD||212 firstname.lastname@example.org|
|Contact: Daniel A Velez, BA||212 email@example.com|
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|Principal Investigator:||Mitchell SV Elkind, MD||Columbia University|